News Archive

ICH - Training on Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports

2nd February 2023

The ICH Secretariat is pleased to announce the publication of Module I - Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video.

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ICH - Training on Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Product

2nd February 2023

The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022. Following the adoption of this Guideline, a Step 4 Introductory Training Presentation has been developed by the Q13 Expert Working Group.

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MHRA - Changes to completed paediatric studies guidance text

2nd February 2023

MHRA have made changes made to the Completed paediatric studies guidance text and suggested a new cover letter on their website.

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MHRA - Fees Consultation Outcome

2nd February 2023

MHRA - Fees Consultation Outcome

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MHRA - Innovation Office Guidance

2nd February 2023

MHRA Innovation Office: guidance and support - can provide access to world-class regulatory knowledge, expertise and experience from within the MHRA.

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MRC - Motion capture tech could predict disease progression

2nd February 2023

MRC - Motion capture tech could predict disease progression

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PIC/S - Adoption and Entry into force of New GDP Guidance Documents

2nd February 2023

Adoption and Entry into force of New GDP Guidance Documents

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WHO - OpenWHO courses

2nd February 2023

Three years of pandemic learning response: reaching learners across the world with life-saving health knowledge

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ICH - ICH M10 on bioanalytical method validation - Scientific guideline

30th January 2023

ICH M10 on bioanalytical method validation - Scientific guideline

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PharmaTechnica - Free Annex 1 Presentation

30th January 2023

A presentations on Annex 1 presented by GMP Inspector Dr Rainer Gnibl is now available (sign up required).

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